The Efficacy of Individualized Dietary Advice in Improving Diet Quality and Cardiovascular Health

NCT03854461 | Completed Results

• 1 other identifier: DK120870-01
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a a randomized controlled parallel group dietary intervention conducted over six months in participants at high risk of cardiovascular disease living in Ireland (North and South) to evaluate the efficacy of individualized dietary advice incorporating biomarker profiles in improving diet quality and cardiometabolic outcomes.

Conditions

Cardiovascular Diseases

Keywords

individualised dietary advice; biomarkers; diet quality; cardiometabolic health

Outcome Measures

Primary Outcomes (1)

• Difference in Mean Change in Prime Diet Quality Score Between Groups Between Months 0 and 6

  Dietary quality will be assessed using an online version of the Prime Diet Quality Score (PDQS). Foods are classified as healthy and unhealthy. Points are assigned according to the following criteria: 0-1 serving/wk (0 point) compared with 2-3 servings/wk (1 point) compared with ≥4 servings/wk (2 points) for the healthy food groups. Scoring is reversed and points deducted for the unhealthy food groups. Points for each food group are summed to give an overall score. The PDQS has 21 food groups and ranges from 0 to 42 total score (scores on a scale), with a higher score indicating a better diet quality.

  Baseline and six months

Secondary Outcomes (11)

• Alcohol Consumption

  Baseline and six months

• Medication Use

  Baseline and six months

• Physical Activity

  Baseline and six months

• Anthropometric Data - Weight

  Baseline and six months

• Anthropometric Data - Waist to Hip Ratio

  Baseline and six months

Study Arms (2)

Educational material

ACTIVE COMPARATOR

Participants will be given written educational material to encourage dietary change towards a better quality diet. Educational material will be adapted from resources used in previous dietary intervention studies.

Behavioral: Educational material

Personalised dietary advice and educational material

EXPERIMENTAL

Participants will also be given the educational material, but will be encouraged to make dietary change using individualized recommendations incorporating food markers of specific components of a high quality diet. Food markers of diet quality will be used to develop an algorithm to deliver personalized dietary advice. Based on biomarker data, a system of categorization of biomarker status will be developed, alongside dietary advice related to this biomarker categorization, and decision trees created, as previously described in the Food4Me study, to ensure standardized delivery of advice within this intervention arm.

Behavioral: Personalised dietary advice and educational material

Interventions

Personalised dietary advice and educational material BEHAVIORAL

As within arm/group description

Personalised dietary advice and educational material

Educational material BEHAVIORAL

As within arm/group description

Educational material

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be considered eligible to enroll in the study if they are:
• overweight (BMI \>27 and ≤ 45 kg/m2),
• have low Prime Diet Quality Score (PDQS \<15) and
• have a combination of risk factors which places them at high total risk (estimated multifactorial CVD risk ≥ 20% over ten years) of developing atherosclerotic CVD for the first time.

You may not qualify if:

• Participants will be ineligible to enroll in the study if they have:
• established diabetes mellitus, CVD or a medical condition or dietary restriction(s) that would substantially limit their ability to complete the study requirements,
• have an excessive alcohol consumption (\>28 Units/week for men or \>21 Units/week for women),
• have a low predicted likelihood to change dietary habits
• are unable to provide informed consent.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• University College Dublin: collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Centre for Public Health, Institute of Clinical Sciences A, Queen's University Belfast, Grosvenor Road, Royal site. Road

Belfast, Northern Ireland, BT12 6BA, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Prof. Jayne Woodside
• Organization: Queen's University Belfast

j.woodside@qub.ac.uk

+44 (0)28 9097 8942

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcomes will be conducted blind, including the primary outcome (diet quality score), laboratory analysis and cardiometabolic health marker assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomised parallel group dietary intervention: two group.

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 26, 2019
• Study Start: January 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-08

Locations

GB (1)